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510(k) K220063

Single Use Cytology Brush by Zhejiang Chuangxiang Medical Technology Co., Ltd. — Product Code FDX

K220063 is an FDA 510(k) premarket notification submitted by Zhejiang Chuangxiang Medical Technology Co., Ltd. for the device "Single Use Cytology Brush". The FDA issued a decision of Substantially Equivalent on July 28, 2022. The device falls under product code FDX (Endoscopic Cytology Brush), a Class II device regulated under 21 CFR 876.1500. Zhejiang Chuangxiang Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2022
Date Received
January 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

Other clearances by Zhejiang Chuangxiang Medical Technology Co., Ltd.

  • K253132 — Single use stone retrieval balloons (March 6, 2026)
  • K251890 — Disposable Ureteral Stents (February 20, 2026)
  • K230773 — Endoscopy Irrigation Tubing (November 21, 2023)
  • K231471 — Air/Water Bottle Tubing, CO2 Source Tubing (September 8, 2023)
  • K212669 — Single Use Hemoclip (May 27, 2022)
  • K220065 — Single Use Ureteral Access Sheath (May 25, 2022)
  • K212668 — Sclerotherapy Needle (February 23, 2022)
  • K191900 — Single Use Grasping Forceps (March 27, 2020)
  • K192258 — Disposable Valve Sets (December 30, 2019)
  • K173758 — Disposable Biopsy Valve (May 14, 2018)

Other clearances for product code FDX

  • K250993 — Single Use Cytology Brush V (BC-V600P-3010) (December 18, 2025)
  • K192908 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes (November 14, 2019)
  • K191485 — Deflectable Brush Biopsy Set (June 26, 2019)
  • K182231 — Brush Biopsy Set ; Deflectable Brush Biopsy Set (May 1, 2019)
  • K181317 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (February 8, 2019)
  • K172663 — Cytology Brush (March 5, 2018)
  • K171573 — Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush (December 29, 2017)
  • K171607 — Bronchi and Gastrointestinal Cytology Brush (July 31, 2017)
  • K151889 — Infinity ERCP Sampling Device (July 30, 2015)
  • K103437 — US ENDOSCOPY CYTOLOGY BRUSH (December 23, 2010)

FDA data resources